Multi-directional catheter control handle

ABSTRACT

An apparatus for deflecting a distal portion of a catheter, a sheath, a medical device, or other flexible elongate member may generally include a handle portion, a pair of adjusting knobs, and deflection wires. The adjusting knobs may be rotatably coupled to the handle portion and operably coupled to the deflection wires. The deflection wires may be in further communication with the distal portion of the flexible elongate member. Rotation of the adjustment knobs may translate or otherwise displace particular deflection wires with respect to the rest of the flexible elongate member, thereby causing the distal portion of the flexible elongate member to deflect. Further, the deflection wires may be oriented such that the distal portion of the flexible elongate member may be deflected in a multitude of directions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/333,641, filed May 11, 2010, which is hereby incorporated byreference as though fully set forth herein.

BACKGROUND OF THE INVENTION

a. Field of the Invention

The present disclosure relates to catheters and other maneuverablemedical devices. More specifically, the present disclosure relates to amulti-direction control handle for steerable catheters and othermaneuverable medical devices.

b. Background Art

Catheters (i.e., catheters or sheaths) that have flexible tubular bodieswith deflectable distal ends and control handles for controlling distalend deflection are used for many noninvasive medical procedures. Forexample, catheters having conductive electrodes along the distal ends oftheir bodies are commonly used for intra-cardiac electrophysiologystudies. The distal end of a catheter body is typically placed into apatient's heart to monitor and/or record the intra-cardiac electricalsignals during electrophysiology studies or during intra-cardiacmapping. The orientation or configuration of the distal end iscontrolled via an actuator located on the catheter's control handle,which remains outside the patient's body. The electrodes conduct cardiacelectrical signals to appropriate monitoring and recording devices thatare operatively connected at the control handle.

Typically, a catheter body is cylindrical and electricallynon-conductive. The catheter body includes a flexible tube constructedfrom polyurethane, nylon or other electrically non-conductive flexiblematerial. The catheter body further includes braided steel wires orother non-metallic fibers in its wall as reinforcing elements. Eachelectrode has a relatively fine electrically conductive wire attachedthereto and extending through the catheter body. The conductive wireextends from the distal end to a proximal end where electricalconnectors such as plugs or jacks are provided to be plugged into acorresponding socket provided in a recording or monitoring device.

The distal portion of the catheter body is selectively deformed into avariety of curved configurations using the actuator on the controlhandle. The actuator is commonly internally linked to the distal portionof the catheter body by at least one deflection wire. Some catheterbodies employ a single deflection wire, which is pulled (i.e., placed intension) by the actuator in order to cause the distal portion of thecatheter body to deform. Other catheter bodies have at least twodeflection wires, where the displacement of one wire (i.e., placing onewire in tension) results in the other wire going slack (i.e., the wiredoes not carry a compressive load). In such catheters, where thedeflection wires are not adapted to carry compressive loads (i.e., thedeflection wires are only meant to be placed in tension), the deflectionwires are commonly called pull or tension wires.

To deform the distal end of the catheter body into a variety ofconfigurations, a more recent catheter design employs a pair ofdeflection wires that are adapted such that one of the deflection wirescarries a compressive force when the other deflection wire carries atensile force. In such catheters, where the deflection wires are adaptedto carry both compressive and tension loads, the deflection wires arecommonly called push/pull or tension/compression wires and thecorresponding catheter actuators are called push-pull actuators.

Prior art control handles for controlling distal end deflection ofcatheter bodies have several drawbacks that adversely impact thehandles' ability to be operated. First, the control handles are oftenexcessively bulky. Second, the control handles are often inadequate withrespect to their ability to provide finely controlled deflectionadjustment for the distal end of the catheter body. Third, the controlhandles often provide inadequate deflection wire travel for a desiredmedical procedure. Fourth, the control handles often have a mechanicaladvantage that is less than desirable and, as a result, requiresignificant effort to operate on the part of a user. Fifth, once adesired body distal end deflection has been reached, the control handlestypically require the physician to take a conscious step to maintain thecatheter at the desired deflection. Sixth, the wire displacementmechanisms within the control handles have a tendency to permanentlydeform the deflection wires. Seventh, the wire displacement mechanismswithin the control handles typically make it difficult, if notimpossible, to provide a lumen that runs uninterrupted from the proximalend of the control handle to the distal end of the catheter body.

There is therefore a need for a catheter that minimizes or eliminatesone or more of the problems set forth above.

BRIEF SUMMARY OF THE INVENTION

Despite advancements in automated, computerized, and electrical medicaltechnology, many physicians and other medical professionals continue toexpress a preference for mechanical handles for maneuvering catheters orother flexible elongate members within a patient. The present disclosurecontemplates one such largely-mechanical, multi-directional cathetercontrol handle that may be used alone or in conjunction with othermedical technology. In particular, one embodiment of themulti-directional catheter control handle may comprise a support member,a flexible elongate member, first and second pairs of deflection wires,and first and second adjusting knobs.

The support member may extend along a longitudinal axis and provide astructural framework for supporting a variety of components of thecontrol handle. The flexible elongate member, which may in some cases bea catheter body or sheath, may have a proximal portion and a distalportion. The proximal portion may extend within or generally couple tothe support member. The distal portion of the flexible elongate memberoften refers to the portion of the flexible elongate member that isfurthest away from the support member or control handle. Further, thedistal portion of the flexible elongate member is typically a portion ofa medical device that supports at least one electrode, an ultrasonicfan, or the like for delivering treatment, performing ablation, mappinginternal organs, etc.

The first and second pairs of deflection wires may be operably coupledto both the distal portion of the flexible elongate member and the firstand second adjusting knobs. For example, the first pair of deflectionwires may be operably coupled to the first adjusting knob, and thesecond pair of deflection wires may be operably coupled to the secondadjusting knob. The first and second adjusting knobs may be rotatablycoupled to the support member such that each adjusting knob can rotateabout the longitudinal axis of the support member.

Moreover, in one embodiment the deflection wires may be oriented aboutor within the flexible elongate member and its distal portion in agenerally orthogonal configuration. Accordingly, rotation of the firstadjusting knob may deflect the distal portion right and left whilerotation of the second adjusting knob may deflect the distal portionanterior and posterior. To that end, when the first adjusting knob isrotated, one of the first pair of deflection wires may be placed intension, pulling on one side of the distal portion causing it to moveright. If the first adjusting knob is rotated in a different direction,the other deflection wire of the first pair may be placed in tension,pulling on an opposing side of the distal portion causing it to moveleft. Similarly, when the second adjusting knob is rotated, one of thesecond pair of deflection wires may be placed in tension, pulling onanother side of the distal portion causing it to move anterior. If thesecond adjusting knob is rotated in a different direction, the otherdeflection wire of the second pair may be placed in tension, pulling onyet another side of the distal portion causing it to move posterior.

In one embodiment, the multi-directional catheter control handle mayinclude a first and second pair of slide members for displacing thedeflection wires. The slide members may be generally axiallydisplaceable along the support member. Further, the first pair of slidemembers may operably couple the first pair of deflection wires to thefirst adjusting knob, while the second pair of slide members mayoperably couple the second pair of deflection wires to the secondadjusting knob. Yet further, in one embodiment one of the first pair ofslide members may have right hand threads while the other of the firstpair may have left hand threads. The same may be true for the secondpair of slide members. Both right hand and left hand internal threadsmay be disposed within the adjusting knobs for engagement with both theright hand and left hand external threads of the slide members. Thuswhen the first adjusting knob is rotated, the first pair of slidemembers move in opposing directions, thereby placing one of the firstpair of deflection wires in tension and thereby releasing any tension inthe other deflection wire of the first pair. And thus when the secondadjusting knob is rotated, the second pair of slide members move inopposing directions, thereby placing one of the second pair ofdeflection wires in tension and thereby releasing any tension in theother deflection wire of the second pair.

By turning the adjusting knobs one at a time, the distal portion of theflexible elongate member may be deflected in four cardinal directions inrelation to the deflection wires and the remainder of the flexibleelongate member. However, when the adjusting knobs are turned insequence or in combination, the distal portion may be oriented at anglesthat are oblique in relation to the deflection wires and the rest of theflexible elongate member.

In some embodiments, the internal and external threads of the adjustingknobs and the slide members may be square threads. Square threads have aself-locking characteristic where thread slippage is less likely tooccur than with traditional-shaped threads.

In one embodiment, the control handle may include at least one stop pinaffixed to the support member. The stop pin may prevent a pair of slidemembers from translating too far so as to strain or damage one of thedeflection wires. Moreover, the stop pin may in some embodiments bepositioned so as to prevent both sets of slide members from beingover-displaced.

In still other embodiments, two deflection wires may be used as opposedto some other number of deflection wires. Two deflection wires may beused with the control handle when the deflection wires are capable ofcarrying both compressive and tensile loads. Thus, with reference to thecontrol handle, each deflection wire is capable of “pushing” and“pulling” on the distal portion of the flexible elongate member. Forexample, pulling on one deflection wire may bend the distal portion 180degrees to the right with respect to the rest of the flexible elongatemember. Yet pushing the same deflection wire may bend the distal portionof the flexible elongate member 180 degrees to the left. By analogy, thesame could be accomplished in anterior and posterior directions with asecond deflection wire. And further, the distal portion could still beoriented at oblique angles by displacing the two deflection wires insequence or in combination.

Even further embodiments of the multi-directional control handlecontemplate alternatives to the adjusting knobs as described above. Forexample, one embodiment may include a right-left adjusting knob that isdisposed along a top surface of the handle. An anterior-posterioradjusting knob may be disposed along a side of the handle. From theperspective of a user with the control handle in front of the user,rotating the right-left adjusting knob clockwise may deflect the distalportion of the flexible elongate member to the right. Rotating theright-left adjusting knob counter-clockwise may deflect the distalportion of the flexible elongate member to the left. Similarly, rotatingthe anterior-posterior adjusting knob forward may deflect the distalportion anterior, while rotating the same knob backwards may deflect thedistal portion posterior. Such an embodiment may be particularlyintuitive for a user.

Still another embodiment of the multi-directional control handle mayinclude a feature where the distal portion of the flexible elongatemember deflects at a rate similar to that at which the adjusting knobsare rotated. This feature may be particularly advantageous because theuser may recognize how far the distal portion is deflected in variousdirections just by looking at the adjusting knobs along the controlhandle.

The foregoing and other aspects, features, details, utilities, andadvantages of the invention will be apparent from reading the followingdescription and claims, and from reviewing the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of one embodiment of the present invention,which is a control handle for a catheter or sheath.

FIG. 2 is an isometric view of the handle exploded to show its variouscomponents.

FIG. 3 is a longitudinal sectional elevation of the handle taken alongsection line AA of FIG. 1.

FIG. 4 is an isometric view of the right and left slides with theirrespective deflection wires attached.

FIG. 5 is a side elevation of an exemplary slide illustrating a means ofslidably securing a deflection wire to the proximal end of the slide.

FIG. 6 is a longitudinal sectional elevation of the adjusting knob takenalong section line AA of FIG. 1.

FIG. 7 is a plan view of another embodiment of the handle.

FIG. 8 is a side elevation of the handle depicted in FIG. 7.

FIG. 9 is an isometric view of the distal end of the handle depicted inFIG. 7.

FIG. 10 is a longitudinal sectional plan view of the handle taken alongsection line BB of FIG. 9.

FIG. 11 is a longitudinal sectional plan view of the knob taken alongsection line BB in FIG. 9.

FIG. 12 is a right side isometric view of the slides displaced about thewire guide.

FIG. 13 is a left side isometric view of the slides displaced about thewire guide.

FIG. 14 is a longitudinal sectional elevation of the handle grip takenalong section line CC in FIG. 7.

FIG. 15 is a latitudinal sectional elevation of the handle grip takenalong section line DD in FIG. 8.

FIG. 16 is an isometric view of the distal end of a control handle for acatheter wherein the handle has a through lumen.

FIG. 17 is an isometric view of the slides, the wire guide, the wiretubing, and the lumen illustrating the path the lumen takes through thehandle.

FIG. 18 is an elevation view of the extreme proximal end surfaces of theslides as viewed from arrow A in FIG. 17 and illustrating the path thelumen and wire tubing take into the passage formed by the channels ofthe slides.

FIG. 19 is an isometric view of the lumen, deflection wires, andelectrical wires of the tube exiting the catheter body-retaining nut onthe distal end of the handle.

FIG. 20 is an isometric view of another embodiment of the handleexploded to show its various components.

FIG. 21 is a longitudinal sectional elevation taken along section lineZZ in FIG. 20.

FIG. 22 is isometric views of the slides oriented to show theirrespective portions of the passage and their planar slide faces.

FIG. 23 is an isometric view of another embodiment of the handleexploded to show its various components.

FIG. 24 is a longitudinal sectional elevation of the handle taken alongsection line YY of FIG. 23.

FIG. 25 is the same longitudinal sectional elevation of the adjustingknob as depicted in FIG. 24, except the adjusting knob is shown byitself.

FIG. 26 is a side elevation of the slides.

FIG. 27A is a latitudinal sectional elevation of the handle, as takenalong section line XX in FIG. 24, wherein the wire guide has a squarecross section.

FIG. 27B is the same latitudinal sectional elevation depicted in FIG.27A, except the wire guide has a circular cross section and a key/groovearrangement.

FIG. 28 is a side elevation of one embodiment of the wire guide equippedwith a groove.

FIG. 29 is a longitudinal sectional elevation of another embodiment ofthe handle taken along section line YY of FIG. 23.

FIG. 30 is a longitudinal sectional plan view of the handle depicted inFIG. 29 taken along section line VV in FIG. 23 and wherein section lineVV forms a plane that is perpendicular to the plane formed by sectionline YY in FIG. 23.

FIG. 31 is an isometric view of one embodiment of the wire guide.

FIG. 32 is a latitudinal sectional elevation of the handle as takenalong section line WW in FIG. 29.

FIG. 33 is a longitudinal sectional elevation of the handle taken alongsection line AA of FIG. 1.

FIG. 34 is a side elevation of an exemplary slide employed in theembodiment depicted in FIG. 33.

FIG. 35 is a longitudinal sectional elevation of the adjusting knobtaken along section line AA of FIG. 1.

FIG. 36 is a diagrammatic illustration of the control handle of thesubject invention being employed in a surgical procedure on a patient.

FIG. 37 is an isometric view of one embodiment of the present invention,which is a multi-directional catheter control handle for a catheter, asheath, a medical device, or other flexible elongate member.

FIG. 38 is an isometric view of the lumen, multiple deflection wires,and electrical wires of the tube exiting the nozzle-like projection onthe distal end of a multi-directional catheter control handle.

FIG. 39 is an isometric view of an embodiment of a multi-directionalcatheter control handle exploded to show its various components.

FIGS. 40-42 are top views of embodiments of a multi-directional cathetercontrol handle in various states of sub-assembly.

FIG. 43 is a top view of an embodiment of a multi-directional cathetercontrol handle in a state of sub-assembly where a wire guide is beinglocated within an adjusting knob insert.

FIG. 44 is an isometric view of a multi-directional catheter controlhandle with a grip handle removed to show perspective.

FIG. 45 is an isometric view of a multi-directional catheter controlhandle with a grip handle and an adjusting knob removed to showperspective.

FIGS. 46A-46E and corresponding FIGS. 47A-47E show side and top views,respectively, of a distal portion of a partially-deflected catheter,sheath, medical device, or other flexible elongate member.

FIGS. 48A-48E and corresponding FIGS. 49A-49E show side and top views,respectively, of a distal portion of a more-fully-deflected catheter,sheath, medical device, or other flexible elongate member.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is an isometric view of one embodiment of the present invention,which is a control handle 2 for a flexible tubular body 4 of a catheter5. Throughout this specification, the terms catheter and flexibleelongate member are meant to include, without limitation, catheters,sheaths, and similar medical devices. As shown in FIG. 1, in oneembodiment, the distal end of the handle 2 is connected to the catheterbody 4 and the proximal end of the handle 2 is connected to tubing 6that contains electrical wire and extends to an electrical connector 8.The handle 2 includes an adjusting knob 10 and a handle grip 12. As willbecome clear from this specification, the handle 2 of the presentinvention is advantageous in that it is compact and allows a user tomanipulate the catheter body's extreme distal end 14 in a bi-directionalmanner by pivoting the adjusting knob 10 relative to the handle grip 12in one direction or the other about the longitudinal axis of the handle2. Furthermore, in one embodiment, the handle 2 has a lumen that runsuninterrupted from the proximal end of the handle 2 to the extremedistal end 14 of the catheter body 4. This lumen can be used to providecontrast injection for guide wire insertion.

For a more detailed discussion of the handle 2, reference is now made toFIGS. 2 and 3. FIG. 2 is an isometric view of the handle 2 exploded toshow its various components. FIG. 3 is a longitudinal sectionalelevation of the handle 2 taken along section line AA of FIG. 1.

As shown in FIGS. 2 and 3, the adjusting knob 10 is pivotally attachedto a mounting shaft (i.e., a slide base or base portion) 16 containedwithin the handle grip 12. To pivotally attach the knob 10 to themounting shaft 16, a dowel pin 18 is inserted into a pinhole 20 in thedistal end of the shaft 16 and mates with a groove 22 in a hub portion23 of the knob 10. A silicone o-ring 24 exists between the hub portion23 of the knob 10 and the distal end of the shaft 16.

As indicated in FIGS. 2 and 3, a wire guide 26 is positioned within theadjusting knob 10 and is held in place by a retaining ring 28. A rightslide or member 30 and a left slide or member 32 are slideablypositioned within a slot (i.e., a slide compartment) 34 in the mountingshaft 16. A catheter body-retaining nut 36 is used to secure thecatheter body 4 to the distal end of the wire guide 26.

As illustrated in FIG. 3, a pair of deflection wires 38 extend from theextreme distal end 14 of the body 4, through the body 4, the wire guide26 and a passage 40 formed between the two slides 30, 32, to a pointnear a proximal portion of the slides 30, 32. Each wire 38 then affixesto an individual slide 30, 32 via a retention screw 42.

For a more detailed discussion of the slides 30, 32 and theirrelationship to the deflection wires 38, reference is now made to FIG.4, which is an isometric view of the deflection wires 38 a, 38 battached to the right and left slides 30, 32. As shown in FIG. 4, theslides 30, 32, which are mirror images of each other, each have arectangular box-like proximal portion 44 and a half-cylinder distalportion 46. Each proximal portion 44 has a generally planar outersidewall and bottom wall. These planar surfaces slideably displaceagainst the generally planar sides and bottom of the slot 34, which actas thrust surfaces for the slides 30, 32.

Each half-cylinder distal portion 46 is hollowed out along itslongitudinal axis to form the passage 40 through which the deflectionwires 38 a, 38 b and, as indicated in FIG. 3, the narrow proximalportion of the wire guide 26 extend when the slides 30, 32 are in theassembled handle 2. Each slide 30, 32 has a planar slide face 48 that ismeant to slideably abut against the planar slide face 48 of the opposingslide 30, 32. Thus, as illustrated in FIG. 2, when the planar slidefaces 48 of the slides 30, 32 abut against each other and the extremeproximal ends of each slide 30, 32 are flush with each other, thehalf-cylinder distal portions 46 of each slide 30, 32 combine to form acomplete cylinder with a channel or passage 40 there through.

As shown in FIG. 4, in one embodiment, the proximal end of eachdeflection wire 38 a, 38 b forms a loop 50 through which a retentionscrew 42 passes to secure the wire 38 a, 38 b to the proximal portion ofthe respective slide 30, 32. As indicated in FIG. 5, which is a sideelevation of an exemplary slide 30, in one embodiment, the proximal endof each deflection wire 38 forms a knot 52. The wire 38 passes through ahollow tension adjustment screw 54 and the knot 52 abuts against thehead 55 of the screw 54, thereby preventing the wire 38 from beingpulled back through the screw 54. In one embodiment, the screw'slongitudinal axis and the longitudinal axis of the slide 30, 32 aregenerally parallel. Each tension adjustment screw 54 is threadablyreceived in the proximal end of its respective slide 30, 32. Tension ina wire 38 may be increased by outwardly threading the wire's tensionadjustment screw 54. Conversely, tension in a wire 38 may be decreasedby inwardly threading the wire's tension adjustment screw 54.

As can be understood from FIG. 4, in one embodiment where the wires 38a, 38 b are intended to only transmit tension forces, the wires 38 a, 38b may deflect or flex within an open area 45 defined in the proximalportion 44 of each slide 30, 32 when the slides 30, 32 displacedistally. Similarly, as can be understood from FIG. 5, in anotherembodiment where the wires 38 are intended to only transmit tensionforces, the wires 38 may slide proximally relative to the screw 54 whenthe slides 30, 32 displace distally.

As shown in FIG. 4, in one embodiment, the outer circumference of thehalf-cylinder distal portion 46 of the right slide 30 is threaded with aright-hand thread 56, and the outer circumference of the half-cylinderdistal portion 46 of the left slide 32 is threaded with a left-handthread 58. In one embodiment, the outer circumference of thehalf-cylinder distal portion 46 of the right slide 30 is threaded with aleft-hand thread, and the outer circumference of the half-cylinderdistal portion 46 of the left slide 32 is threaded with a right-handthread.

For a better understanding of the relationship of the slide threads 56,58 to the rest of the handle 2, reference is now made to FIG. 6, whichis a longitudinal sectional elevation of the adjusting knob 10 takenalong section line AA of FIG. 1. As indicated in FIG. 6, a cylindricalhole or shaft 60 passes through the knob 10 along the knob'slongitudinal axis. In the hub portion 23 of the knob 10, the innercircumferential surface of the shaft 60 has both right hand threads 62and left hand threads 64. These internal threads 62, 64 of the knob 10mate with the corresponding external threads 56, 58 of the slides 30,32. More specifically, the right internal threads 62 of the knob 10 matewith the right external threads 56 of the right slide 30, and the leftinternal threads 64 of the knob 10 mate with the left external threads58 of the left slide 32.

Thus, as can be understood from FIGS. 2, 3, 4 and 6, in one embodiment,as the knob 10 is rotated clockwise relative to the longitudinal axis ofthe handle 2, the internal and external right threads 62, 56 engage andthe internal and external left threads 64, 58 engage, thereby causingsimultaneous opposed displacement of the right and left slides 30, 32longitudinally within the slot 34 in the handle 10. Specifically,because of the threading arrangement of the knob 10 and the slides, 30,32, the right slide 30 moves distally within the slot 34 and the leftslide 32 moves proximally within the slot 34 when the knob 10 is rotatedclockwise relative to the handle grip 12 of the handle 2. Conversely,when the knob 10 is rotated in a counterclockwise manner relative to thehandle grip 12 of the handle 2, the right slide 30 moves proximallywithin the slot 34 and the left slide 32 moves distally within the slot34.

As can be understood from FIGS. 4 and 6, when the knob 10 is rotatedsuch that the right slide 30 is urged distally and the left slide 32 isurged proximally, the deflection wire 38 a connected to the right slide30 is placed into compression and the deflection wire 38 b connected tothe left slide 32 is placed into tension. This causes the extreme distalend 14 of the catheter body 4 to deflect in a first direction.Conversely, when the knob 10 is rotated such that the right slide 30 isurged proximally and the left slide 32 is urged distally, the deflectionwire 38 a connected to the right slide 30 is placed into tension and thedeflection wire 38 b connected to the left slide 32 is placed intocompression. This causes the extreme distal end 14 of the catheter body4 to deflect in a second direction that is opposite the first direction.

The control handle 2 of the present invention as described has severaladvantages. First, the handle 2 is compact and may be operated with asingle hand. Second, the threaded slides 30, 32 and knob 10 allow aphysician to make fine, controlled adjustments to the bend in the distalend 14 of the catheter body 4. Third, once the knob 10 is rotated so asto cause a bend in the distal end 14 of the catheter body 4, the threads56, 58, 62, 64 interact to maintain the bend without requiring anyaction on the physician's part. Fourth, because the slides 30, 32 simplydisplace distally and proximally along the longitudinal axis of thehandle 2, they are less likely to permanently deform the wires 38 ascompared to the wire displacement mechanisms in some prior art handles.Fifth, the threads 56, 58, 62, 64 are mechanically advantageous in thatthey provide increased deflection wire travel and reduced actuationeffort for the physician, as compared to some prior art handles.

While FIGS. 2-6 depict an embodiment where the slides 30, 32 haveexternal threads 56, 58 and the knob 10 has internal threads 62, 64, inother embodiments the threading arrangement is reversed. For adiscussion of one such embodiment, reference is made to FIGS. 33-35.FIG. 33 is a longitudinal sectional elevation of the handle 2 takenalong section line AA of FIG. 1. FIG. 34 is a side elevation of anexemplary slide employed in the embodiment depicted in FIG. 33. FIG. 35is a longitudinal sectional elevation of the adjusting knob taken alongsection line AA of FIG. 1.

A comparison of the embodiment depicted in FIGS. 33-35 to the embodimentdepicted in FIGS. 3, 5 and 6 reveals that the two embodiments aregenerally the same, except as will be described in the followingdiscussion of FIGS. 33-35. Reference numbers utilized in FIGS. 33-35pertain to the same or similar features identified by the same referencenumbers in FIGS. 3, 5 and 6.

As shown in FIG. 33, the adjusting knob 10 is pivotally attached to amounting shaft (i.e., a slide base or base portion) 16 contained withinthe handle grip 12. A wire guide 26 is positioned within the adjustingknob 10. Like the embodiment depicted in FIG. 2, the embodimentillustrated in FIG. 33 includes a right slide or member 30 and a leftslide or member 32 that are slideably positioned within a slot (i.e., aslide compartment) 34 in the mounting shaft 16.

As can be understood from FIG. 34, the slides 30, 32, which are mirrorimages of each other, each have a rectangular box-like proximal portion44 and a distal portion 46 that may be rectangular or half-cylindrical.Each proximal portion 44 has a generally planar outer sidewall andbottom wall. These planar surfaces slideably displace against thegenerally planar sides and bottom of the slot 34, which act as thrustsurfaces for the slides 30, 32.

Each distal portion 46 is hollowed out to form half of a cylindricalpassage 40 that is created when the slides 30, 32 are abutted againsteach other in a side-by-side relationship. Thus, each distal portion 46of each slide 30, 32 includes an inner circumferential surface, whichwhen combined with the inner circumferential surface of the other slide30, 32, defines the cylindrical passage 40.

As indicated in FIG. 34, in one embodiment, the inner circumferentialsurface of the right slide 30 is threaded with a right-hand thread 56.Similarly, as can be understood from FIG. 34, the inner circumferentialsurface of the left slide 32 is threaded with a left-hand thread 58.Thus, the distal portion 46 of each slide 30, 32 is equipped withinternal threads. In another embodiment, the inner circumferentialsurface of the right slide 30 is threaded with a left-hand thread 58.Similarly, the inner circumferential surface of the left slide 32 isthreaded with a right-hand thread 56.

As indicated in FIG. 35, the knob 10 includes an outer hub 23 asurrounding an inner hub 23 b. A space 65 exists between, and is definedby, the inner and outer hubs 23 a, 23 b. The space 65 is adapted toreceive the distal ends 46 of each slide 30, 32. The outercircumferential surface of the inner hub 23 b has both right handthreads 62 and left hand threads 64. These external threads 62, 64 ofthe knob 10 mate with the corresponding internal threads 56, 58 of theslides 30, 32. More specifically, the right external threads 62 of theknob 10 mate with the right internal threads 56 of the right slide 30,and the left external threads 64 of the knob 10 mate with the leftinternal threads 58 of the left slide 32.

As can be understood from FIG. 33, in one embodiment, as the knob 10 isrotated clockwise relative to the longitudinal axis of the handle 2, theinternal and external right threads 56, 62 engage and the internal andexternal left threads 58, 64 engage, thereby causing simultaneousopposed displacement of the right and left slides 30, 32 longitudinallywithin the slot 34 in the handle 10. Specifically, because of thethreading arrangement of the knob 10 and the slides, 30, 32, the rightslide 30 moves distally within the slot 34 and the left slide 32 movesproximally within the slot 34 when the knob 10 is rotated clockwiserelative to the handle grip 12 of the handle 2. Conversely, when theknob 10 is rotated in a counterclockwise manner relative to the handlegrip 12 of the handle 2, the right slide 30 moves proximally within theslot 34 and the left slide 32 moves distally within the slot 34.

As can be understood from FIG. 33, when the knob 10 is rotated such thatthe right slide 30 is urged distally and the left slide 32 is urgedproximally, the deflection wire 38 connected to the right slide 30 isplaced into compression and the deflection wire 38 connected to the leftslide 32 is placed into tension. This causes the extreme distal end 14of the catheter body 4 to deflect in a first direction. Conversely, whenthe knob 10 is rotated such that the right slide 30 is urged proximallyand the left slide 32 is urged distally, the deflection wire 38connected to the right slide 30 is placed into tension and thedeflection wire 38 connected to the left slide 32 is placed intocompression. This causes the extreme distal end 14 of the catheter body4 to deflect in a second direction that is opposite the first direction.

For a detailed discussion of another embodiment of the handle 2 of thepresent invention, reference is now made to FIGS. 7, 8 and 9. FIG. 7 isa plan view of the handle 2. FIG. 8 is a side elevation of the handle 2.FIG. 9 is an isometric view of the distal end of the handle 2.

As shown in FIGS. 7-9, the handle 2 includes an adjusting knob 10 on itsdistal end and a handle grip 12 on its proximal end. As can beunderstood from FIGS. 7-9, in one embodiment, the knob 10 has agenerally circular cross-section and the handle grip 12 has a generallyoval cross-section. In one embodiment, both the knob 10 and the handlegrip 12 have generally circular cross-sections. The oval cross-sectionof the handle grip 12 is advantageous because it provides the physicianwith a tactile indication of the catheter's rotational position.

For a more detailed discussion of the components of the handle 2,reference is now made to FIG. 10, which is a longitudinal sectional planview of the handle 2 taken along section line BB of FIG. 9. As shown inFIG. 10, an o-ring 24 is located between the handle grip 12 and a groovein the knob 10. The knob 10 is pivotally affixed to the handle grip 12via a rotating retaining-ring 60 that resides within grooves in both theknob and the handle grip 12.

As illustrated in FIG. 10, a catheter body-retaining nut 36 isthreadably affixed to the distal end of a wire guide 26 that extendsalong the axial center of the knob 10. As indicated in FIG. 10 and moreclearly shown in FIG. 11, which is a longitudinal sectional plan view ofthe knob 10 taken along section line BB in FIG. 9, a cylindrical hole orshaft 60 passes through the knob 10 along the knob's longitudinal axis.The inner circumferential surface of the shaft 60 has both right handthreads 62 and left hand threads 64 that extend towards the distal endof the knob 10 from a hub portion 23 of the knob 10. As shown in FIG.11, in one embodiment, the knob 10 is a singular integral piece.

As indicated in FIG. 10, a right slide 30 and a left slide 32 arelongitudinally displaceable within the handle 2 and about the proximalend of the wire guide 26. As shown in FIGS. 12 and 13, which are,respectively, a right side isometric view of the slides 30, 32 displacedabout the wire guide 26 and a left side isometric view of the slides 30,32 displaced about the wire guide 26, each slide 30, 32 has a planarslide face 48 that abuts and slideably displaces against the slide face48 of the opposed slide 30, 32. Also, each slide 30, 32 has a channel 40that combines with the channel 40 of the opposed slide 30, 32 to form apassage 40 through which the proximal end of the wire guide 26 passes asthe slides 30, 32 displace about the wire guide 26. As shown in FIG. 10,the passage 40 formed by the channels 40 also provides a pathway alongwhich the deflection wires 38 a, 38 b (represented by dashed lines inFIG. 10) travel from a proximal portion of the slides 30, 32, throughthe wire guide 26, and onward to the extreme distal end 14 of thecatheter body 4.

As indicated in FIGS. 12 and 13, each slide 30, 32 has a half-cylinderdistal portion 46 and a shorter and wider half-cylinder proximal portion47. The right slide 30 has a right-handed thread 56 on its distalportion 46. Similarly, the left slide 32 has a left-handed thread 58 onits distal portion 46. Thus, as can be understood from FIG. 10, when theknob 10 is rotated in a clockwise direction relative to the handle grip12, the right handed threads 62 within the knob 10 engage the righthanded threads 56 of the right slide 30, and the left handed threads 64within the knob 10 engage the left handed threads 58 of the left slide32. As a result, the right slide 30 is distally displaced within thehandle 2 and the left slide 32 is proximally displaced within the handle2. Accordingly, the deflection wire 38 a attached to the right slide 30is pushed (i.e., subjected to a compressive force) and the deflectionwire 38 b attached to the left slide 32 is pulled (i.e., subjected to atension force). Conversely, if the knob is rotated counterclockwise, theopposite displacement of the slides 30, 32 and deflection wires 38 a, 38b will occur.

As indicated in FIG. 10, each deflection wire 38 a, 38 b is attached tothe proximal portion 47 of its respective slide 30, 32 via retentionscrews 42. The retention screws, which are more clearly illustrated inFIGS. 12 and 13, are threadably mounted in the proximal portions 47.

As shown in FIGS. 12 and 13, each half-cylindrical proximal portion 47of a slide 30, 32 has an upper and lower planar notch 64 adjacent theirrespective planar slide faces 47. The function of these notches 64 maybe understood by referring to FIGS. 14 and 15.

FIG. 14 is a longitudinal section elevation of the handle grip 12 takenalong section line CC in FIG. 7. FIG. 15 is a latitudinal sectionelevation of the handle grip 12 taken along section line DD in FIG. 8.As shown in FIGS. 14 and 15, the handle grip 12 is one integral piecehaving an interior cylindrical void 66 in which the proximal portions 47of the slides 30, 32 may displace as indicated in FIG. 10.

As shown in FIGS. 14 and 15, upper and lower ribs 68 extend from thewalls that form the interior cylindrical void 66. The ribs 68 runlongitudinally along a substantial portion of the cylindrical void'slength. As can be understood from FIGS. 12-15, the upper planar notches64 on the proximal portions 47 of the slides 30, 32 interface with, anddisplace along, the upper rib 68 as the slides 30, 32 displace withinthe cylindrical void 66. Similarly, the lower planar notches 64 on theproximal portions 47 of the slides 30, 32 interface with, and displacealong, the lower rib 68 as the slides 30, 32 displace within thecylindrical void 66. Thus, the ribs 68 act as thrust surfaces for theslides 30, 32.

For a detailed discussion of another embodiment of the handle 2 depictedin FIGS. 7-15, reference is now made to FIG. 16. FIG. 16 is an isometricview of the distal end of a control handle 2 for a catheter 5 whereinthe handle 2 and catheter body 4 have a through lumen 70. As shown inFIG. 16, in one embodiment, the lumen 70 and the electrical wire tube 6,which extends to the electrical connector 8, pass through strain reliefs71 and into the proximal end of the handle grip 12. In one embodiment,the lumen 70 terminates at its proximal end with a stopcock 72. In oneembodiment, the stopcock 72 has a hemostasis seal 74 that can beutilized for guide wire insertion. While a long flexible length of lumen70, as depicted in FIG. 16, provides motion isolation while insertingcontrast from a syringe, in one embodiment, the lumen 70 does not extendfrom the handle grip 12. Instead, the stopcock 72 or luer fitting issimply attached to the lumen 70 where it exits the proximal end of thehandle grip 12.

For a better understanding of the path of the lumen 70, reference is nowmade to FIGS. 17, 18 and 19. FIG. 17 is an isometric view of the slides30, 32, the wire guide 26, the wire tubing 6, and the lumen 70illustrating the path the lumen 70 takes through the handle 2. FIG. 18is an elevation view of the extreme proximal end surfaces of the slides30, 32 as viewed from arrow A in FIG. 17 and illustrating the path thelumen 70 and wire tubing 6 take into the passage 40 formed by thechannels 40 of the slides 30, 32. FIG. 19 is an isometric view of thelumen 70, deflection wires 38 a, 38 b, and electrical wires 76 of thewire tube 6 exiting the catheter body-retaining nut 36 on the distal endof the handle 2.

As shown in FIGS. 17 and 18, the lumen 70 and the wire tubing 6 passthrough their respective reliefs 71 and into the passage 40 formed bythe channels 40 in each slide 30, 32. In one embodiment, soon after thewire tubing 6 and the lumen 70 enter the passage 40, the wires 76 of thewire tubing 6 exit the wire tubing 6 and are dispersed about the outercircumference of the lumen 70 as depicted in FIG. 19.

As illustrated in FIG. 17, in another embodiment, after the wire tube 6and lumen 70 enter the passage 40, the wire tube 6 and the lumen 70continue on their pathway to the distal end 14 of the catheter body 4 bypassing, in a side-by-side arrangement, through the remainder of thepassage 40 formed into the slides 30, 32 and into an internal passagethat extends along the longitudinal axis of the wire guide 26. Near theend of the wire guide 26, the wire 76 exists the wire tube 6. The wire76, lumen 70 and deflection wires 38 a, 38 b then pass into the catheterby exiting the catheter body-retaining nut 36 of the handle as indicatedin FIG. 19.

For a detailed discussion of another embodiment of the handle 2,reference is now made to FIG. 20, which is an isometric view of thehandle 2 exploded to show its various components. As can be understoodfrom FIG. 20, the features of the handle 2 depicted in FIG. 20 aresimilar to the features of the handle depicted in FIG. 2, except thehandle 2 depicted in FIG. 20 is configured to have a relatively large,generally uniform in diameter, pathway extend the full length of thehandle 2 (i.e., from the distal opening 102 in the wire guide 26,through the passage 40 defined in the slides 30, 32 and through an exithole 104 in the proximal end of the shaft 16).

The configuration of the handle 2 that allows a relatively largegenerally uniform in diameter pathway to pass through the length of thehandle 2, as depicted in FIG. 20, is more clearly shown in FIG. 21,which is a longitudinal sectional elevation taken along section line ZZin FIG. 20. As illustrated in FIG. 21, in one embodiment, the pathway100, which includes the passage through the wire guide 26 and thepassage 40 through the slides 30, 32, is large enough that the catheterbody 4 itself may pass through the pathway 100 and be connected to theproximal end of the shaft 16 at the exit hole 104. Thus, in oneembodiment, to prevent the catheter body 4 from rotating with theadjusting knob 10, the catheter body 4 is affixed to the shaft 16 at theexit hole 104. In one embodiment, the catheter body 4 runs the fulllength of the handle 4 as depicted in FIG. 21, except the body 4 isaffixed to the wire guide 26 at or near the distal opening 102. In otherembodiments, the catheter body 4 is affixed to both the wire guide 26 ator near the distal opening 102 and the shaft 16 at the exit hole 104.

As can be understood from FIG. 21 and as more clearly depicted in FIG.22, which is isometric views of the slides 30, 32 oriented to show theirportions of the passage 40 and their planar slide faces 48, the passage40 is large enough in diameter to displace over the outer diameter ofthe wire guide 26. As shown in FIGS. 21 and 22, a catheter body passage110 passes through the proximal portion 44 of each slide 30, 32, therebyallowing the slides 30, 32 to displace back and forth over the outersurface of the catheter body 4.

As indicated in FIG. 21, in one embodiment, the catheter body 4 has anopening 111 in its wall that allows the wires 38 to exit the body 4 andconnect to the slides 30, 32. In one embodiment, the wires 38 connect tothe slides 30, 32 via tension adjustment screws 54 as previouslydiscussed.

Due to the configuration of the slides 30, 32, the wire guide 26 and theshaft 16, the catheter body 4 may run uninterrupted the full length ofthe handle 2. As a result, electrical wiring 76 (see FIG. 19) and alumen 70 may be routed the full length of the handle 2 by way of thebody 4.

For a detailed discussion of another embodiment of the handle 2 of thepresent invention, reference is now made to FIGS. 23 and 24. FIG. 23 isan isometric view of the handle 2 exploded to show its variouscomponents. FIG. 24 is a longitudinal sectional elevation of the handle2 taken along section line YY of FIG. 23. Generally speaking, thefeatures of the handle 2 depicted in FIGS. 23 and 24 are similar to thefeatures of the handle depicted in FIG. 20, except the two embodimentsemploy different slider arrangements. For example, the embodimentsdepicted in FIGS. 1-22 employ parallel slides or members 30, 32 (i.e.,the slides 30, 32 exist within the handle 2 in a parallel orside-by-side arrangement). As will be understood from FIGS. 23 and 24and the following figures, in the embodiment of the handle 2 depicted inFIGS. 23 and 24, the slides or members 150, 152 exist within theadjustment knob 10 in a series arrangement (i.e., the slides 150, 152are not parallel or side-by-side to each other, but are orientedend-to-end along a longitudinal axis of the handle 2).

As shown in FIGS. 23 and 24, the adjusting knob 10 is pivotally coupledto the distal end of the mounting shaft (i.e., base portion) 16. Thewire guide 26 extends through the center of the adjusting knob 10 andthe mounting shaft 16. The catheter body 4 is coupled to the distal endof the wire guide 26 and, in one embodiment, extends through the wireguide 26 and out of the proximal end of the mounting shaft 16.

As shown in FIGS. 23 and 24, a distal slide 150 is located in a distalportion of the adjusting knob 10, and a proximal slide 152 is located ina proximal portion (i.e., hub portion 23) of the adjusting knob 10. Asillustrated in FIG. 24, the outer surface of each slide 150, 152 hasthreads 154 that mate with threads 156 on an interior surface of theadjusting knob 10.

As illustrated in FIG. 24, each deflection wire 38 a, 38 b travels alongthe interior of the wire guide 26 until it exits the wire guide 26 at ahole 157 in the sidewall of the wire guide 26. Each deflection wire 38a, 38 b then extends to the slide 150, 152 to which the deflection wire38 a, 38 b is attached. In one embodiment, in order to attach to a slide150, 152, a deflection wire 38 a, 38 b passes through a passage 159 inthe slide 150, 152 and attaches to a hollow tension adjustment screw 54via a knot 52 as previously described in this Detailed Description.

For a better understanding of the orientation of the threads 154, 156,reference is now made to FIGS. 25 and 26. FIG. 25 is the samelongitudinal sectional elevation of the adjusting knob 10 as it isdepicted in FIG. 24, except the adjusting knob 10 is shown by itself.FIG. 26 is a side elevation of the slides 150, 152.

As shown in FIGS. 25 and 26, in one embodiment, the distal slide 150 hasright hand threads 154 that engage right hand threads 156 in the distalportion of the adjusting knob 10, and the proximal slide 152 has lefthand threads 154 that engage left hand threads 156 in the proximalportion of the adjusting knob 10. Thus, as can be understood from FIGS.23-26, when the adjusting knob 10 is rotated relative to the mountingshaft 16 in a first direction about the longitudinal axis of the handle2, the slides 150, 152 will converge along the wire guide 26, therebycausing the first wire 38 to be placed into tension and the second wire38 to be compressed. As a result, the distal end 14 of the catheter body4 will deflect in a first direction. Similarly, when the adjusting knob10 is rotated in a second direction that is opposite from the firstdirection, the slides 150, 152 will diverge along the wire guide 26,thereby causing the first wire 38 to be compressed and the second wire38 to be placed into tension. As a result, the distal end 14 of thecatheter body 4 will deflect in a second direction generally oppositefrom the first direction.

In one embodiment, to prevent the slides 150, 152 from simply rotatingaround the wire guide 26 when the adjusting knob 10 is rotated, theslides 150, 152 and wire guide 26 are configured such that the slides150, 152 will displace along the wire guide 26, but not rotationallyaround it. For example, as indicated in FIG. 27A, which is a latitudinalsectional elevation of the handle 2 as taken along section line XX inFIG. 24, the wire guide 26 has a square cross section that mates with asquare hole 162 running the length of the slide 150, 152. Theinteraction between the square hole 162 and the square cross section ofthe wire guide 26 prevents a slide 150, 152 from rotating about the wireguide 26, but still allows the slide 150, 152 to displace along thelength of the wire guide 26.

In another embodiment, as shown in FIG. 27B, which is the samelatitudinal sectional elevation depicted in FIG. 27A, each slide 150,152 has a hole 162 with a circular cross section. Each hole 162 runs thelength of its respective slide 150, 152 and includes a key 160 thatextends into the hole 162 from the interior circumferential surface ofthe hole 160. The key 160 engages a groove or slot 158 that runs alongthe length of the wire guide 26 as depicted in FIG. 28, which is a sideelevation of one embodiment of the wire guide 26. The interactionbetween the key 160 and the slot 158 prevents a slide 150, 152 fromrotating about the wire guide 26, but still allows the slide 150, 152 todisplace along the length of the wire guide 26.

As shown in FIGS. 27A and 27B, a hollow shaft 165 extends through thewire guide 26. This allows a catheter body 4 with a lumen to extendcompletely through the handle 2 as shown in FIG. 24.

For a detailed discussion of another embodiment of the handle 2 that issimilar to the embodiment depicted in FIG. 23, reference is now made toFIGS. 29 and 30. FIG. 29 is a longitudinal sectional elevation of thehandle 2 as if taken through section line YY of FIG. 23. FIG. 30 is alongitudinal sectional plan view of the handle 2 as if taken throughsection line VV in FIG. 23 and wherein section line VV forms a planethat is perpendicular to the plane formed by section line YY in FIG. 23.

As illustrated in FIGS. 29 and 30, the handle 2 includes an adjustingknob 10 pivotally coupled to the distal end of the mounting shaft (i.e.,base portion) 16. In one embodiment, the adjusting knob 10 includes aproximal end 170, a distal end 172 and a threaded shaft 173, which isconnected to the proximal end 170 and extends distally along thelongitudinal axis of the adjusting knob 10. The threaded shaft 173includes a distal end 174, a proximal end 176, a series of right handthreads 178 along a distal portion of the shaft 173, and a series ofleft hand threads 180 along a proximal portion of the shaft 173.

As shown in FIGS. 29 and 30, a distal slide 150 is located in a distalportion of the adjusting knob 10, and a proximal slide 152 is located ina proximal portion (i.e., hub portion 23) of the adjusting knob 10. Eachslide has a hole 155 through which the threaded shaft 173 passes. Theinner circumferential surface of the hole 155 for the distal slide 150has right hand threads that mate with the right hand threads 178 on thedistal portion of the shaft 173. Similarly, the inner circumferentialsurface of the hole 155 for the proximal slide 152 has left hand threadsthat mate with the left hand threads 180 on the proximal portion of theshaft 173. In other embodiments, the locations for the left and rightthreads are reversed.

As can be understood from FIGS. 29, 30 and 31, which is an isometricview of one embodiment of the wire guide 26, a hollow center shaft 182extends from the distal end of the wire guide 26, through the threadedshaft 173 of the adjustment knob 10, and to the proximal end of the baseshaft 16. Thus, in one embodiment, a catheter body 4 may be routedthrough the lumen 165 of the wire guide's hollow center shaft 182 toexit the proximal end of the handle 2, as illustrated in FIGS. 29 and30.

As illustrated in FIG. 29, each deflection wire 38 a, 38 b travels alongthe interior of the wire guide 26 until it exits the wire guide 26 at ahole 157 in the sidewall of the wire guide 26. Each deflection wire 38a, 38 b then extends to the slide 150, 152 to which the deflection wire38 a, 38 b is attached. In one embodiment, in order to attach to a slide150, 152, a deflection wire 38 a, 38 b passes through a passage 159 inthe slide 150, 152 and attaches to a hollow tension adjustment screw 54via a knot 52 as previously described in this Detailed Description.

In one embodiment, as shown in FIG. 29, the deflection wire 38 b leadingto the proximal slide 152 passes through a second passage 161 in thedistal slide 150. The second passage 161 has sufficient clearance thatthe passage 161 may easily displace along the wire 38 b when the distalslide 150 displaces distally and proximally. The second passage 161serves as a guide that stiffens the wire 38 b and helps to reduce thelikelihood that the wire 38 b will bend when compressed.

As can be understood from FIGS. 29 and 30, when the adjusting knob 10 isrotated relative to the mounting shaft 16 in a first direction about thelongitudinal axis of the handle 2, the slides 150, 152 will convergealong the threaded shaft 173, thereby causing the first wire 38 a to beplaced into tension and the second wire 38 b to be compressed. As aresult, the distal end 14 of the catheter body 4 will deflect in a firstdirection. Similarly, when the adjusting knob 10 is rotated in a seconddirection that is opposite from the first direction, the slides 150, 152will diverge along the threaded shaft 173, thereby causing the firstwire 38 a to be compressed and the second wire 38 b to be placed intotension. As a result, the distal end 14 of the catheter body 4 willdeflect in a second direction generally opposite from the firstdirection.

In one embodiment, to prevent the slides 150, 152 from simply rotatingwith the threaded shaft 173 within the adjusting knob 10 when theadjusting knob 10 is rotated, the slides 150, 152 and wire guide 26 areconfigured such that the slides 150, 152 will displace along thethreaded shaft 173, but not rotationally within the adjusting knob 10.For example, as indicated in FIGS. 31 and 32, which is a latitudinalsectional elevation of the handle 2 as taken along section line WW inFIG. 29, the wire guide 26 has right and left semicircular portions 190that oppose each other and extend along the length of the hollow centershaft 182 of the wire guide 26. As shown in FIG. 32, the generallyplanar opposed faces 192 of the semicircular portions 190 abut againstthe generally planar side faces 194 of the slides 150, 152. Thisinteraction prevents a slide 150, 152 from rotating within theadjustment knob 10 when the knob 10 is rotated, but still allows theslide 150, 152 to displace along the length of the threaded shaft 173.

As can be understood from FIG. 36, which is a diagrammatic illustrationof the control handle 2 of the subject invention being employed in asurgical procedure on a patient 200, the distal end 14 of the catheterbody 4 is inserted into the patient 200 (e.g., intravenously via a bodylumen 202 of the patient 200, percutaneously, or via other avenues forentering the patient's body). The distal end 14 of the catheter body 4is advanced until positioned in a selected location within the patient200 (e.g., within a chamber 204 of the patient's heart 206 or otherorgan, with a body cavity of the patient, etc.). The distal end of thecatheter body 4 is then deflected by rotating the adjustment knob 10about a longitudinal axis of a base portion 16. As can be understoodfrom FIGS. 1-35, this causes the slides 30, 32 within the handle 2 todisplace along the longitudinal axis in opposite directions. Since eachslide 30, 32 is coupled to its respective deflection wire 38 and eachdeflection wire 38 runs through the catheter body 4 and is coupled tothe distal end 14, the distal end 14 of the catheter body 4 isdeflected.

In still other embodiments shown in FIGS. 37-49, a multi-directionalcatheter control handle 230 may be used to maneuver the catheter body'sdistal end (or distal end portion or distal portion) into a variety oforientations. The multi-directional catheter control handle 230 mayprovide even further maneuverability in comparison to the embodimentsdiscussed with reference to FIGS. 1-36. The multi-directional cathetercontrol handle 230 enhances maneuverability of the catheter body'sdistal end through the use of a first adjusting knob and a secondadjusting knob, as opposed to one adjusting knob.

FIG. 37 shows one embodiment of the multi-directional catheter controlhandle 230 having a handle grip 232, a right/left (R/L) adjusting knob234, an anterior/posterior (A/P) adjusting knob 236, and a longitudinalaxis 238. With two adjusting knobs 234, the multi-directional cathetercontrol handle 230 may control at least two pairs of deflection wiresthat in turn control the orientation of the catheter body's distal end.

FIG. 38, which has at least one component removed for purposes ofclarity, shows how four deflection wires 240 a through 240 d may beoriented about the lumen 70 adjacent to electrical wires 76. The fourdeflection wires 240 a through 240 d may be operably coupled to theadjusting knobs and to the catheter body's distal end. In oneembodiment, for example, the R/L adjusting knob 234 may control themovement of deflection wires 240 a and 240 b, and the A/P adjusting knob236 may control the movement of deflection wires 240 c and 240 d.Rotating the R/L adjusting knob 234 thus deflects the distal end inright and left directions. Similarly, rotating the A/P adjusting knob236 deflects the distal end in anterior and posterior directions.Movement of the distal end is discussed in more detail below. However,in addition to deflection in four “cardinal” directions (i.e., right,left, anterior, and posterior), one skilled in the art will recognizethat rotating the adjusting knobs 234, 236 in combination or in sequencemay orient the distal end at oblique angles in relation to thedeflection wires 240 and/or in relation to the rest of the flexibleelongate member. Accordingly, the maneuverability of the catheter'sdistal end is enhanced.

The components of one embodiment of the multi-directional cathetercontrol handle 230 that provide for this enhanced maneuverability areshown in an exploded view in FIG. 39. These components can becategorized into three non-mutually exclusive groups: a first group ofcomponents that help achieve both R/L catheter deflection and A/Pcatheter deflection, a second group that is used primarily to achieveA/P catheter deflection, and a third group that is used primarily toachieve R/L catheter deflection. These groups merely facilitatediscussion of the multi-directional catheter control handle 230 and byno means limit the functions, purposes, benefits; or the like of anygiven component. Also, particularly where users integrate R/L deflectionand A/P deflection, components from all of these groups are used todeflect the catheter body's distal end.

The handle grip 232 is one such common component that is useful duringboth R/L and A/P deflection. The handle grip 232 is shown in twosubparts 232 a, 232 b and is located near the proximal end of themulti-directional catheter control handle 230. Forming the handle grip232 from two subparts 232 a, 232 b allows for quick access to internalcomponents, if needed. An end cap 250 and a clip feature 252 may helpretain the handle grip subparts 232 a, 232 b around a mounting shaft 254that acts as a support member for a number of components of the handle230. The end cap 250 may secure generally peripheral rims 256 a, 256 bextending from subparts 232 a, 232 b, respectively. The clip feature 252may be configured to mate with an internal rim 258 on subparts 232 a,232 b to further secure the handle grip 232 around the mounting shaft254.

In addition, a nozzle-like projection 260 may be helpful during both R/Land A/P deflection. The nozzle-like projection 260 may provide strainrelief for the flexible tubular body of a catheter that extends from theprojection 260. Moreover, the nozzle-like projection 260 may haveinternal threads that mate with threads on a wire guide, as discussedbelow.

FIG. 39 also shows components of the multi-directional catheter controlhandle 230 that allow for A/P deflection of the catheter body's distalend. In particular, the handle 230 may include a first slide 270 and asecond slide 272, which may resemble those slides shown in FIG. 4. Theslides 270, 272 may be mirror images of each other and may includeproximal portions 274 and distal portions 276. Deflection wires mayoperably attach to the proximal portions 274 of the first and secondslides 270, 272. For example, a pair of deflection wires 240 c, 240 d ofFIG. 38 may operably attach to the proximal portions 274 of the firstand second slides 270, 272. Hence translation of the first and secondslides 270, 272 may control the pair of deflection wires 240 c, 240 dand ultimately the catheter body's distal end.

The deflection wires may be operably attached to the proximal portions274 through a number of techniques including, for example, using aretention screw or soldering. In some embodiments, for example, theproximal portions 274 of the first and second slides 270, 272 may haveholes through which the deflection wires may slidably extend. Withregard to a single deflection wire, for example, a segment of thedeflection wire that protrudes proximally beyond one of the proximalportions 274 may be attached to a mass of solder that cannot passthrough a hole in the proximal portion 274. Translating the proximalportion 274 of a slide proximally from a “neutral position,” asdescribed further below, may translate the mass of solder and theattached deflection wire proximally. But when the proximal portion 274is translated distally from the neutral position, the slidably attacheddeflection wire and the mass of solder may remain largely stationary. Inthese embodiments, rotation of the corresponding adjusting knob altersthe tension in only one of the pair of deflection wires at a time. Someamount of slack in one of a pair of deflection wires can be advantageouswhere the distal end of the catheter is maneuvered into a variety oforientations using both the R/L adjusting knob 234 and the A/P adjustingknob 236.

Moreover, the distal portion 276 of the first slide 270 may containright-handed square threads, while the distal portion 276 of the secondslide 272 may contain left-handed square threads. By configuring theslides 270, 272 with square threads, the slides 270, 272 do not, or atleast are less likely to, revert after displacement. Square threads havea self-locking property that makes them less susceptible to threadslippage or back-out. Similar to the slides shown in FIG. 12, the slides270, 272 may be hollowed so as to form a passage 278 for various wiresof the catheter including, for example, the lumen and deflection wires240. And further, the slides 270, 272 may be positioned within themounting shaft 254 such that they may translate, but are prevented fromrotating due to the contours of their proximal portions 274 and themounting shaft 254.

To translate the first and second slides 270, 272, an adjusting knobinsert 280 with square internal threading may be provided. The adjustingknob insert 280 may be rotatably coupled to the mounting shaft 254 byinserting a hub portion 282 of the insert 280 into a distal opening 284of the mounting shaft 254. A dowel pin 286 may be inserted into anangular pinhole 288 to secure a groove 290 on the hub portion 282. Oncerotatably coupled, the adjusting knob insert 280 may rotate about thelongitudinal axis 238, but is prevented from translating along thelength of the mounting shaft 254. The adjusting knob insert 280 may haveright-handed and left-handed internal threads similar to those shown inFIG. 11, except that the threads in the insert 280 may be squarethreads. Thus, the distal portions 274 of the first and second slides270, 272 may be inserted within the adjusting knob insert 280, with theinternal threads of the insert 280 engaging with the external threads,or parts thereof, of the slides 270, 272.

When the adjusting knob insert 280 rotates one way, the first slide 270may translate in a direction opposite the second slide 272. When theadjusting knob insert 280 rotates the other way, each slide 270, 272 maytranslate, respectively, in a reverse direction. This back and forthtranslation of the slides 270, 272 is one aspect of the catheter handle230 that allows for A/P deflection.

Still referring to FIG. 39, the multi-directional catheter controlhandle 230 may also include a wire guide 300 positioned within theadjusting knob insert 280 and the passage 278 formed by the first andsecond slides 270, 272. To prevent the wire guide 300 from rotating whenthe adjusting knob insert 280 rotates, the wire guide 300 may haveprojections 302 that can be inserted within slots 304 within the firstand second slides 270, 272. Because the first and second slides 270, 272do not rotate relative to the mounting shaft 254, neither does the wireguide 300 once the projections 302 are inserted within the slots 304.Further, at least one washer and a retaining ring 306 may hold a distalend (not shown) of the wire guide 300 in place within the adjusting knobinsert 280. The distal end of the wire guide 300 may be threaded toallow for engagement with internal threads disposed in the nozzle-likeprojection 260. Yet further, the A/P adjusting knob 236 may bepress-fitted onto a distal portion 310 of the adjusting knob insert 280.The A/P adjusting knob 236 may provide a more effective contact surfacefor a user of the handle 230 as opposed to the adjusting knob insert 280itself. In an alternative embodiment, the A/P adjusting knob 236 may beintegral with the distal portion 310 of the adjusting knob insert 280such that the A/P adjusting knob 236 need not be press-fitted onto thedistal portion 310. In either case, internal threads may be said to bedisposed within the A/P adjusting knob 236.

In addition, FIG. 39 shows components of the multi-directional cathetercontrol handle 230 that allow for R/L deflection of the catheter body'sdistal end. In particular, a right slide 320 and a left slide 322 may beprovided. The right slide 320 may include a proximal tab 324 thatextends through a slot 326 in the mounting shaft 254 when a flat portion328 of the right slide 320 is positioned against the mounting shaft 254.Once positioned, the right slide 320 and the proximal tab 324 maytranslate along a portion of the length of the mounting shaft 254. Theright slide 320 may further include a set of right-hand square threads330 for engagement with internal threads (not shown) of the R/Ladjusting knob 234. Similar to the square threads on the first andsecond slides 270, 272, the square threads 330 on the right slide 320prevent, or at least reduce the likelihood of, thread slippage orback-out.

Similar to the right slide 320, the left slide 322 may also include aproximal tab 340 that extends through a slot 342 in the mounting shaft254 when a flat portion 344 of the left slide 322 is positioned againstthe mounting shaft 254. Once positioned, the left slide 322 and theproximal tab 340 may also translate proximally and distally in relationto the mounting shaft 254. When both right and left slides 320, 322 arepositioned against the mounting shaft 254, the proximal tab 340 of theleft slide 322 may sit below the proximal tab 324 of the right slide320. Similarly, the left slide 322 may also include a set of left-handsquare threads 346 for engagement with internal threads of the R/Ladjusting knob 234. Hence the R/L adjusting knob 234 may haveright-handed and left-handed internal threads similar to those shown inFIG. 11, except that the threads in the R/L adjusting knob 234 may besquare threads. Rotating the R/L adjusting knob 234 about thelongitudinal axis 238 may cause the right and left slides 320, 322 totranslate in opposite directions along the length of the handle 230.

The proximal tabs 324, 340 may provide points of attachment fordeflection wires, such as the pair of deflection wires 240 a, 240 bshown in FIG. 38, for example. Just like the first and second slides270, 272, deflection wires may be attached to the proximal tabs 324, 340through a number of techniques including, for example, using a retentionscrew or soldering. Hence when the R/L adjusting knob 234 translates theright and left slides 320, 322 in opposite directions, a tensile forceon at least one of the two attached deflection wires—different thanthose controlled by the A/P adjusting knob 236—is either increased ordecreased.

It should be noted that although the terms “first,” “second,” “right,”“left,” “R/L,” and “A/P” are used herein, such terms are merely for thebenefit of this detailed description. Hence the first and second slidescould be referred to as a first pair of slide members, for example, andthe right and left slides could be referred to as a second pair of slidemembers. Likewise, the same can be said for the adjusting knobs,deflection wires, and so on. Moreover, some embodiments of themulti-directional catheter control handle may operate without two pairsof slide members. Rather, two slide members may be used. By way ofexample, a first slide member may be operably coupled to a first pair ofdeflection wires and to one adjusting knob, while a second slide membermay be operably coupled to a second pair of deflection wires and toanother adjusting knob. One exemplary way a single slide member couldcontrol a pair of deflection wires is to attach the deflection wires toopposite sides of the slide member. Attaching the slide member at apoint between the opposite sides to a pivot would allow for conversemovement of the attached deflection wires.

Once the right and left slides 320, 322 are positioned alongside themounting shaft 254, the R/L adjusting knob 234 may be rotatably coupledto the mounting shaft 254. In one embodiment, the R/L adjusting knob 234may be assembled around the right and left slides 320, 322 and themounting shaft 254. The internal threads of the R/L adjusting knob 234may engage or partially engage the right-hand and left-hand squarethreads 330, 346. To keep the R/L adjusting knob 234 from translatingalong the mounting shaft 254, stop blocks 350 may be inserted throughapertures 352 in the R/L adjusting knob 234 and openings 354 in themounting shaft 254. As such, the stop blocks 350 may ride along thesurface of the hub portion 282 of the adjusting knob insert 280. Morespecifically, the stop blocks 350 may be positioned in a ring groove(not shown) disposed within the R/L adjusting knob 234 such that the R/Ladjusting knob 234 may rotate about the mounting shaft 254, but isprevented from translating along the length of the mounting shaft 254.In other words, the stop blocks 350 may extend away from the hub portion282 and into a ring groove within the R/L adjusting knob 234, but thestop blocks 350 do not occupy the apertures 352 of the R/L adjustingknob 234. To cover the apertures 352 and prevent contaminants fromentering the handle 230, caps 356 may be placed over the apertures 352.

In one embodiment, the multi-directional catheter control handle 230 mayalso include at least one deflection stop pin 360, which may extendfully or partially within the mounting shaft 254. Deflection stop pins360 may be positioned between the proximal portions 274 of the first andsecond slides 270, 272 and the proximal tabs 324, 340 of the right andleft slides 320, 322. The deflection stop pins 360 may prevent theslides 270, 272, 320, 322 from being over-displaced so as to strain,stretch, deform, break, or otherwise damage one of the deflection wires.Accordingly, when at least one of the slides 270, 272, 320, 322 contactsthe deflection stop pins 360, one or both of the pairs of deflectionwires may be fully deflected and thus the adjusting knobs 236, 234 maynot be rotated further in that direction. In another embodiment, thestop pins 360 may limit the movement of only the first and second slides270, 272.

Referring now to FIG. 40, components of one embodiment of themulti-directional catheter control handle 230 are shown in a state ofsub-assembly. Namely, the mounting shaft 254, the first and secondslides 270, 272, and the adjusting knob insert 280 are shown to bepartially assembled. The hub portion 282 of the adjusting knob insert280 may extend through the distal opening 284 of the mounting shaft 254.The dowel pin 286, however, has not yet been inserted. The distalportion 276 of the second slide 272 has been fully inserted within theadjusting knob insert 280, with the proximal portion 274 of the secondslide 272 protruding. With the second slide 272 fully inserted into theadjusting knob insert 280, the first slide 270 may be inserted into theadjusting knob insert 280. As the adjusting knob insert 280 is rotatedwithin the mounting shaft 254, the second slide 272 is backed out of theadjusting knob insert 280 and the first slide 270 is drawn into theadjusting knob insert 280. The slides 270, 272 translate in oppositedirections due to the right-hand square threads on the first slide 270,the left-hand square threads on the second slide 272, and the right- andleft-hand internal threading within the adjusting knob insert 280.

The second slide 272 may be backed out of the adjusting knob insertuntil it is generally even with the first slide 270, as shown in FIG.41. The first and second slides 270, 272 come to a neutral positionwhere they are equally inserted within the adjusting knob insert 280.This position is neutral because from this point each slide 270, 272 canmove an equal distance proximal to or distal from the adjusting knobinsert 280. This means that each slide 270, 272 can cause an attacheddeflection wire to deflect the catheter body's distal end to the samedegree, albeit in opposing directions.

FIG. 41 shows one embodiment of the mounting shaft 254 in a state ofsub-assembly similar to that of FIG. 40. In FIG. 41, though, the rightand left slides 320, 322 are shown alongside the mounting shaft 254.Further, the proximal tabs 324, 340 of the right and left slides 320,322 are shown extending through the slots 326, 342 in the mounting shaft254. The right slide 320 is shown to be offset from the left slide 322because the R/L adjusting knob 234 may be assembled around the right andleft slides 320, 322 much like the adjusting knob insert 280 isassembled around the first and second slides 270, 272.

As can be understood from FIG. 42, the R/L adjusting knob 234 may bepositioned around the mounting shaft 254. To secure the R/L adjustingknob 234, the stop blocks may be inserted through the apertures in theR/L adjusting knob 234 and openings in the mounting shaft 254. Once thecaps 356 are placed over the apertures, the right and left slides 320,322 may be positioned within the RA, adjusting knob 234. Like the firstand second slides 270, 272, the right and left slides 320, 322 may alsobe brought to a neutral position. There, each slide 320, 322 may extendgenerally equally within the R/L adjusting knob 234, and one proximaltab 324 may be positioned over the other proximal tab 340, as shown inFIG. 42.

FIG. 42 also illustrates the catheter body 4 extending through thelength of a partially-assembled multi-directional catheter controlhandle 230. This portion of the catheter body 4 that may extend through,or generally couple to, the multi-directional catheter control handle230 or the mounting shaft 254 can be referred to as the proximal portion362 of the catheter body 4. Specifically, the proximal portion 362 ofthe catheter body 4 may extend through the clip feature 252, between theproximal tabs 324, 340, through the gap 278 formed by the first andsecond slides 270, 272, and through the adjusting knob insert 280. Asdiscussed with reference to the embodiments shown in FIGS. 1-36, theproximal portion 362 of the catheter body 4 may have various openings ordiscontinuities to allow deflection wires into the catheter body 4. Thedeflection wire 240 a, which may be attached to the proximal tab 324,may extend along the outside of the proximal portion 362 of the catheterbody 4 and into the passage 278 formed by the first and second slides270, 272. The deflection wire 240 a and other deflection wires (notshown) may enter the proximal portion 362 at one or more discontinuitiesin the catheter body 4, as described above.

Now referring to FIG. 43, the wire guide 300 may be positioned aroundthe catheter body 4, with the end of the wire guide 300 having theprojections 302 being placed into the distal portion 310 of theadjusting knob insert 280. The wire guide 300 may slide into theadjusting knob insert 280 such that the projections 302 slide into theslots in the first and second slides. Ultimately, the distal end 370 ofthe wire guide 300 may be positioned within the distal portion 310 ofthe adjusting knob insert 280. To secure the distal end 370, the atleast one washer and retaining ring (not shown) may be used to maintainthe distal end 370 within the distal portion 310 of the adjusting knobinsert 280. In a final assembly, threads 372 of the distal end 370 mayengage with internal threads on the nozzle-like projection to furtherretain the components of the handle 230.

FIG. 44 shows one embodiment of the multi-directional catheter controlhandle 230 in which the handle grip is removed for purposes of clarity.Moreover, the embodiment shown in FIG. 44 utilizes many of thecomponents that were discussed with reference to FIGS. 20-22. Bycontrast, however, the embodiment shown here includes two adjustingknobs 234, 236 and the right and left slides, 320, 322. This embodimentexemplifies how some of the embodiments discussed with reference toFIGS. 1-36, or at least the components contained therein, may be adaptedfor use with the multi-directional catheter control handle 230.Moreover, FIG. 45 shows the same embodiment as that in FIG. 44, exceptthat the handle grip and the R/L adjusting knob are removed for anadditional perspective.

Although the multi-directional catheter control handle is describedherein for use with a catheter body, such a handle could be used inconjunction with any medical device or flexible elongate member, even inapplications beyond the medical field. Moreover, the multi-directionalcatheter control handle may be compatible with virtually all of theembodiments discussed with reference to FIGS. 1-36. For example,electrodes may be disposed along the catheter body or along the distalportion of the catheter body for delivering therapy, performing ablativeprocedures, mapping internal organs, and the like.

With reference to FIGS. 46A-46E and corresponding FIGS. 47A-47E, thecatheter body's distal end 14 is shown in a variety of orientations thatare caused by the multi-directional catheter control handle. FIGS.46A-46E show side views of the distal end 14, while FIGS. 47A-47E showcorresponding top views of the distal end 14. FIGS. 46A, 47A show thedistal end 14 in a straight, undeflected position 390. Here, althoughnot shown, both the first and second slides and the right and leftslides may be in neutral positions. As a user rotates the R/L adjustingknob, the right and left slides translate in opposite directions, withone of the slides pulling a deflection wire (e.g., deflection wire 240 ain FIG. 38) away from the distal end 14. The result of this tension inthe deflection wire is shown in FIGS. 46B, 47B, with the distal end 14deflected to the right 392. From there, the user may rotate the A/Padjusting knob to cause the first and second slides to translate inopposite directions. Similarly, one of the first or second slides maypull a deflection wire (e.g., deflection wire 240 c in FIG. 38) awayfrom the distal end 14. FIGS. 46C, 47C show the result of this sequence,with the distal end 14 deflected in a posterior direction 394. Toprogress to a deflection 396 shown in FIGS. 46D, 47D, the user maydeflect the R/L adjusting knob in a direction opposite that which wasused to initially deflect the distal end 14. As such, the right and leftslides may respectively translate in directions opposite those taken toarrive at the orientation shown in FIGS. 46B, 47B. With the distal end14 now deflected to the left 396, the user may rotate the A/P adjustingknob in a different direction to arrive at an anterior deflection 398shown in FIGS. 46E, 47E.

Without reiterating the full sequence taken to achieve the variousdeflections shown in FIGS. 46A-46E, 47A-47E, similar steps may be takento achieve the deflections shown in FIGS. 48A-48E, 49A-49E. FIGS.48A-48E show side views of the distal end 14, while FIGS. 49A-49E showcorresponding top views of the distal end 14. FIGS. 48A, 49A show thedistal end 14 in the straight, undeflected position 390. The primarydifference between FIGS. 46B-46E, 47B-47E and FIGS. 48B-48E, 49B-49E isthat the distal end 14 shown in FIGS. 48B-48E, 49B-49E is deflectedfurther than the distal end 14 shown in FIGS. 46B-46E, 47B-47E. Insteadof approximately 90 degree states of deflection, the distal end 14 isshown to be in approximately 180 degree states of deflection. Thus,FIGS. 48B, 49B show the distal end 14 in a rightward deflection 400;FIGS. 48C, 49C show an anterior deflection 402; FIGS. 48D, 49D show aleftward deflection 404; and FIGS. 48E, 49E show a posterior deflection406. Although the adjusting knobs 234, 236 may need to be rotatedfurther to deflect the distal end 14 to 180 degrees, a similar sequenceof rotations of the adjusting knobs 234, 236 may be used to achieve eachdeflection.

One skilled in the art will understand that the distal end 14 is capableof deflection at all different angles under the control of themulti-directional catheter control handle. For example, the distal end14 may be held at a position between FIG. 46D and FIG. 48E, or thedistal end 14 may be deflected less than 90 degrees or greater than 180degrees. Thus FIGS. 46-49 show merely exemplary embodiments of thedistal end 14.

One skilled in the art will also understand how deflecting the distalend (or distal portion) of the catheter may be accomplished withstructures other than those described and depicted above. For example,if push/pull deflection wires (sometimes referred to astension/compression wires) are employed, a first and second pair ofdeflection wires may not be necessary. Rather, a first deflection wireand a second deflection wire could be positioned 90 degrees apart aboutthe lumen, similar to two (e.g., 240 a, 240 d) of the four generallyorthogonal-configured pairs of wires shown in FIG. 38. Since eachpush/pull deflection wire can carry tensile and compressive loads, thereis no need to pair each deflection wire with an additional, opposingdeflection wire.

In still another embodiment, the multi-directional catheter controlhandle could function without adjusting knobs. Instead, the slidemembers could have protrusions that extend from the mounting shaft. Auser could use the protrusions to translate, or axially displace, theslides within the mounting shaft. In yet another embodiment, themulti-directional handle could use adjusting knobs that rotate at thesurface of the mounting shaft or handle grip. For example, one adjustingknob operatively connected (e.g., through a gear system) to one pair ofslides could be placed on the top of the handle such that it does notrotate about a longitudinal axis of the handle. Another adjusting knoboperatively connected to another pair of slides could be placed on theside of the handle. Thus, the two adjusting knobs could be positioned at90 degrees from one another. Moreover, the adjusting knob on the top ofthe handle could control R/L deflection while the adjusting knob on theside of the handle could control A/P deflection. This configurationcould enhance the intuitiveness of the handle, as rotating the topadjusting knob clockwise and counterclockwise would deflect the distalportion of the catheter right and left, and rotating the side adjustingknob forward and backward would deflect the distal portion of thecatheter posterior and anterior.

Even further, the present disclosure contemplates an embodiment wherethe degree of rotation of the adjusting knobs can be made to besubstantially similar to the degree of deflection in the distal portionof the catheter. For example, rotating a R/L adjusting knob 90 degreesto the right may cause the distal portion of the catheter to deflectabout 90 degrees to the right. This characteristic may be accomplishedby using proper thread angles, gear ratios, or the like.

The aforementioned catheter handles may operate with a variety ofcatheter systems such as visualization systems, mapping systems, andnavigation support and positioning systems (i.e., for determining aposition and orientation (P&O) of a flexible elongate member or othermedical device). For example, the catheter handles may be used with anENSITE VELOCITY™ system running a version of NAVX™ software commerciallyavailable from St. Jude Medical, Inc., of St. Paul, Minn. and as alsoseen generally by reference to U.S. Pat. No. 7,263,397 entitled “METHODAND APPARATUS FOR CATHETER NAVIGATION AND LOCATION AND MAPPING IN THEHEART” to Hauck et al., owned by the common assignee of the presentdisclosure, and hereby incorporated by reference in its entirety. Theseexemplary systems with which the catheter handles may be utilized cancomprise conventional apparatus known generally in the art, for example,the ENSITE VELOCITY™ system described above or other known technologiesfor locating/navigating a catheter in space (and for visualization),including for example, the CARTO visualization and location system ofBiosense Webster, Inc., (e.g., as exemplified by U.S. Pat. No. 6,690,963entitled “System for Determining the Location and Orientation of anInvasive Medical Instrument” hereby incorporated by reference in itsentirety), the AURORA™ system of Northern Digital Inc., a magnetic fieldbased localization system such as the GMPS™ system based on technologyfrom MediGuide Ltd. of Haifa, Israel and now owned by St. Jude Medical,Inc. (e.g., as exemplified by U.S. Pat. Nos. 7,386,339, 7,197,354 and6,233,476, all of which are hereby incorporated by reference in theirentireties) or a hybrid magnetic field-impedance based system, such asthe CARTO 3 visualization and location system of Biosense Webster, Inc.(e.g., as exemplified by U.S. Pat. Nos. 7,536,218, and 7,848,789 both ofwhich are hereby incorporated by reference in their entireties). Some ofthe localization, navigation and/or visualization systems can involveproviding a sensor for producing signals indicative of catheter locationand/or distal portion orientation information, and can include, forexample one or more electrodes in the case of an impedance-basedlocalization system such as the ENSITE VELOCITY™ system running NAVX™software, which electrodes can already exist in some instances, oralternatively, one or more coils (i.e., wire windings) configured todetect one or more characteristics of a low-strength magnetic field, forexample, in the case of a magnetic-field based localization system suchas the GMPS™ system using technology from MediGuide Ltd, describedabove.

Although a number of embodiments of this invention have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this invention. For example, alljoinder references (e.g., attached, coupled, connected, and the like)are to be construed broadly and may include intermediate members betweena connection of elements and relative movement between elements. Assuch, joinder references do not necessarily infer that two elements aredirectly connected and in fixed relation to each other. It is intendedthat all matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative only and notlimiting. Changes in detail or structure may be made without departingfrom the spirit of the invention as defined in the appended claims.

1. An apparatus for maneuvering a medical device, the apparatuscomprising: a support member extending along a longitudinal axis; aflexible elongate member having a distal portion and a proximal portion,wherein the proximal portion is operably coupled to the support member;a first adjusting knob and a second adjusting knob, the first and secondadjusting knobs rotatably coupled to the support member, with the firstand second adjusting knobs being rotatable about the longitudinal axis;a first pair of deflection wires operably coupled to the first adjustingknob and to the distal portion of the flexible elongate member; and asecond pair of deflection wires operably coupled to the second adjustingknob and to the distal portion of the flexible elongate member; whereinrotation of the first adjusting knob imparts a tensile force on one ofthe first pair of deflection wires thereby causing the distal portion ofthe flexible elongate member to deflect in a first direction, whereinrotation of the second adjusting knob imparts a tensile force on one ofthe second pair of deflection wires thereby causing the distal portionof the flexible elongate member to deflect in a second direction.
 2. Theapparatus of claim 1 further comprising a first slide member and asecond slide member, the first and second slide members beingdisplaceable along a portion of a length of the support member, whereinthe first slide member is operably coupled to the first adjusting knoband to the first pair of deflection wires, wherein the second slidemember is operably coupled to the second adjusting knob and to thesecond pair of deflection wires.
 3. The apparatus of claim 2 wherein thefirst slide member comprises a first pair of slide members and thesecond slide member comprises a second pair of slide members, said firstand second pairs of slide members being displaceable along the portionof the length of the support member, wherein the first pair of slidemembers is operably coupled to the first adjusting knob and to the firstpair of deflection wires, wherein the second pair of slide members isoperably coupled to the second adjusting knob and to the second pair ofdeflection wires.
 4. The apparatus of claim 3 wherein rotation of thefirst adjusting knob imparts opposing forces on the first pair of slidemembers, wherein rotation of the second adjusting knob imparts opposingforces on the second pair of slide members.
 5. The apparatus of claim 3further comprising: internal threads within the first and secondadjusting knobs; and external threads along the first and second pairsof slide members; wherein rotation of the first and second adjustingknobs causes the internal threads within the first and second adjustingknobs to engage the external threads on the first and second pairs ofslide members and axially displace the first and second pairs of slidemembers.
 6. The apparatus of claim 3 further comprising at least onestop pin affixed to the support member for preventing at least one ofthe pair of slide members from being over-displaced.
 7. The apparatus ofclaim 5 wherein a first slide member of the first pair of slide membershas right hand external threads and a second slide member of the firstpair of slide members has left hand external threads, wherein a firstslide member of the second pair of slide members has right hand externalthreads and a second slide member of the second pair of slide membershas left hand external threads.
 8. The apparatus of claim 5 wherein theexternal threads on the first and second pairs of slide members aresquare external threads and the internal threads within the first andsecond adjusting knobs are square internal threads, wherein the squareexternal and internal threads reduce the likelihood of thread slippage.9. The apparatus of claim 1 wherein rotation of the first adjusting knobimparts a tensile load in only one of the first pair of deflection wiresat a time, wherein rotation of the second adjusting knob imparts atensile load in only one of the second pair of deflection wires at atime.
 10. The apparatus of claim 1 further comprising at least oneelectrode coupled to the flexible elongate member.
 11. The apparatus ofclaim 1 wherein the first and second pairs of deflection wires arepositioned generally orthogonal to one another such that translatingboth the first and second pairs of deflection wires or translating thefirst and second pairs of deflection wires sequentially orients thedistal portion at oblique angles.
 12. The apparatus of claim 1 whereinthe flexible elongate member includes openings where the first andsecond pairs of deflecting wires enter the flexible elongate member. 13.An apparatus for maneuvering a medical device, the apparatus comprising:a support member extending along a longitudinal axis; a flexibleelongate member having a distal portion and a proximal portion, whereinthe proximal portion is coupled to the support member; first and secondadjusting knobs rotatably coupled to the support member, with the firstand second adjusting knobs being rotatable about the longitudinal axis;a first deflection wire operably coupled to the first adjusting knob andto the distal portion of the flexible elongate member; and a seconddeflection wire operably coupled to the second adjusting knob and to thedistal portion of the flexible elongate member; wherein rotation of thefirst adjusting knob imparts one of a compressive force or a tensileforce on the first deflection wire thereby causing the distal portion ofthe flexible elongate member to deflect in a first direction, whereinrotation of the second adjusting knob imparts one of a compressive forceor a tensile force on the second deflection wire thereby causing thedistal portion of the flexible elongate member to deflect in a seconddirection.
 14. The apparatus of claim 13 further comprising at least twoslide members, wherein a first slide member of the at least two slidemembers is operatively coupled to the first deflection wire and to thefirst adjusting knob, wherein a second slide member of the at least twoslide members is operatively coupled to the second deflection wire andto the second adjusting knob, with the at least two slide members beingdisplaceable along the support member.
 15. The apparatus of claim 14wherein rotation of the first and second adjusting knobs causes squareinternal threads disposed within the first and second adjusting knobs toengage square external threads on the at least two slide members andaxially displace the at least two slide members.
 16. An apparatus fordeflecting a distal portion of a flexible elongate member, the apparatuscomprising: a support member having a length; a flexible elongate memberhaving a distal portion and a proximal portion, wherein the proximalportion is operably attached to the support member; a first pair ofslide members and a second pair of slide members, with the first andsecond pairs of slide members supported by the support member and beingtranslatable along a portion of the length of the support member; afirst pair of deflection wires operably attached to the first pair ofslide members and to the distal portion of the flexible elongate member;and a second pair of deflection wires operably attached to the secondpair of slide members and to the distal portion of the flexible elongatemember; wherein translation of the first pair of slide members imparts atensile force on one of the first pair of deflection wires therebycausing the distal portion of the flexible elongate member to deflect ina first direction, wherein translation of the second pair of slidemembers imparts a tensile force on one of the second pair of deflectionwires thereby causing the distal portion of the flexible elongate memberto deflect in a second direction.
 17. The apparatus of claim 16 furthercomprising at least one adjusting knob for translating one of the pairsof slide members.
 18. The apparatus of claim 17 wherein translation ofthe first pair of slide members causes a load in at least one of thefirst pair of deflection wires to approach zero.
 19. The apparatus ofclaim 17 wherein a range through which the distal portion of theflexible elongate member has been deflected is substantially similar toa range through which the at least one adjusting knob has been rotated.20. The apparatus of claim 16 wherein a first slide member of the firstpair of slide members has right hand external threads and a second slidemember of the first pair of slide members has left hand externalthreads, wherein a first slide member of the second pair of slidemembers has right hand external threads and a second slide member of thesecond pair of slide members has left hand external threads.
 21. Theapparatus of claim 16 wherein the first and second pairs of deflectionwires are positioned generally orthogonal to one another such thattranslating both the first and second pairs of deflection wires ortranslating the first and second pairs of deflection wires sequentiallyorients the distal portion at oblique angles.